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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K214091
Device Name Dental Image Plate Scanner, Model DFC-4T-SMART
Applicant
Hefei Dentafilm Medical Equipment Co., Ltd.
# 98 Tangkou Rd.,
Economic And Technological Development Zone
Hefei,  CN 230601
Applicant Contact Ming Chang Qiu
Correspondent
Hefei Dentafilm Medical Equipment Co., Ltd.
# 98 Tangkou Rd.,
Economic And Technological Development Zone
Hefei,  CN 230601
Correspondent Contact Ming Chang Qiu
Regulation Number872.1800
Classification Product Code
MUH  
Date Received12/28/2021
Decision Date 03/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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